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Quality Audits

quality-audits.pngSo we all understand that internal audits and supplier audits are required by regulation.  We also understand that if a company does not have an audit schedule or has one but is not able to fulfill the schedule an observation or noncompliance is likely from the FDA or Notified Body.  However, for the moment, let’s get past the obvious and focus on the real benefit of audits.

If a company manages the audit program in a productive manner (i.e., not as a punitive weapon against employees or suppliers) they will quickly determine the “real” benefits of a solid, productive audit program.  The challenge often is that a company does not utilize qualified auditors.  Not simply qualified in auditing techniques but an auditor that is familiar with the regulations and most importantly the subject material they are auditing.  In this blog, let’s discuss the internal audit program.

If qualified and unbiased, an internal auditor should be able to identify clear noncompliance with company processes and the inadequacies of the process itself.  There findings will be able to identify how operational processes do not speak to each other or are disconnected.  All of these findings create an inefficient operation and frustrated employees.  In addition, when such environments exist, these operational processes present the most “ripe” environment for noncompliance that will cause FDA 483 findings, Warning Letters and, potentially, unsafe medical products. 

It is understandable that a company is nervous about a robust internal audit program.  Internal politics and uncovering “skeletons” present events that can cause friction within a company.  However, the reality is that it is infinitely more manageable to discover your own problems instead of a third part finding the problem.  The cost of the later event is significantly higher than the former.  Additionally, if managed effectively, an internal audit program presents a clear message to employees that the company wants to be the best it can be in providing medical products and services.

RQMIS provides consultants with extensive auditing experience (including former FDA field employees involved in inspections).  We provide an unbiased assessment of not only the compliance of your quality system but also whether the operational process is creating inefficiencies out of the belief it is compliant with FDA regulations or international standards. 

What are your thoughts on maintaining an internal audit program?  Is your company’s program just something that must get done without a serious commitment from management? Do you see benefits of using outside consultants?

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President/founder of RQMIS Inc. a consulting company with experience in the Medical Device/Biotechnology Industry focused on Regulatory/Clinical/Quality Affairs and Product Management.   RQMIS Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).


Seven years experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District.  This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start-up and large multinational medical device companies.  Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea. 


Provides companies with regulatory and clinical strategic advice on bringing novel technologies to the United States and EU markets in the clinical fields of orthopaedics/neurosurgery/diabetic care (spine, restorative/reconstructive, sports medicine and wound healing), gastroenterology/urology/gynecology/pulmonology/cardiology/plastic surgery  (endoscopy/laparoscopy/minimally invasive/biliary stents).  The devices involved have included active implantables, long term implants, electromechanical, ultrasonic imaging and PACS products. 

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